Stroke, Acute
Conditions
Brief summary
Prehospital providers encounter patients with suspected stroke frequently. Prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers. This device will identify large vessel stroke to ultimately improve triage decisions and optimize outcomes.
Detailed description
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
Interventions
DEVICEHarmony
Passive recording of the head pulse
Sponsors
Wayne State University
MindRhythm, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
• suspected stroke in the prehospital setting
Exclusion criteria
* scalp laceration * Patient refusal * Prisoner, other vulnerable population * Prehospital provider feels that the recording may interfere with care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary effectiveness objective is to estimate the sensitivity and specificity of LVO diagnosis with Harmony®. | Through study completion, an average of 6 months | The subject's final discharge diagnosis based on the CTA scan and the neurologist's assessment will serve as the ground truth diagnosis. The sensitivity and specificity will be estimated as the point estimate (Harmony® identified correctly divided by the ground truth number); the confidence intervals will be estimated by the Clopper-Pearson method (exact intervals for proportions). |
Countries
United States
Outcome results
None listed